This is an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
Unnamed facility
Ankara, Turkey (Türkiye)
Unnamed facility
Ankara, Turkey (Türkiye)
Unnamed facility
Antalya, Turkey (Türkiye)
Unnamed facility
Balcali/Adana, Turkey (Türkiye)
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 6 months
Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
Time frame: Up to 6 months
Number of death
Time frame: Up to 6 months
Number of participants with serious adverse events as a measure of safety and tolerability
Time frame: Up to 6 months
Progression-Free Survival (PFS)
The PFS is defined as the time from date of treatment assignment (i.e., date of first treatment) to date of first observed disease progression or death due to any cause, if death occurs while the subject is in the study (that is, by the last visit including during the safety follow-up visit date), and before progression is observed.
Time frame: Up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Bursa, Turkey (Türkiye)
Unnamed facility
Gaziantep, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Izmir, Turkey (Türkiye)
Unnamed facility
Kayseri, Turkey (Türkiye)
...and 1 more locations